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Abstract：
BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of fruquintinib-based therapy as a salvage therapy for patients with advanced or metastatic sarcoma, including soft tissue sarcoma (STS) and bone sarcoma.
METHODS: Patients with advanced or metastatic sarcoma were divided into two groups. One group received fruquintinib monotherapy, while the other received fruquintinib combined therapy. Safety and efficacy of fruquintinib-based therapy were recorded and reviewed retrospectively, including progression-free survival (PFS), overall response rate (ORR), and adverse events (AEs).
RESULTS: Between August 2021 and December 2022, 38 sarcoma patients were retrospectively included. A total of 14 patients received fruquintinib alone (including 6 STS and 8 bone sarcoma), while 24 were treated with fruquintinib combined therapy (including 2 STS and 22 bone sarcoma). The median follow-up was 10.2 months (95% CI, 6.4-11.5). For the entire population, the median PFS was 8.0 months (95% CI, 5.5-13.0). The ORR was 13.1%, while the disease control rate (DCR) was 86.8%. The univariate analysis showed that radiotherapy history (HR, 4.56; 95% CI, 1.70-12.24; p = 0.003), bone sarcoma (HR, 0.34; 95% CI, 0.14-0.87; p = 0.024), and treatment method of fruquintinib (HR, 0.36; 95% CI, 0.15-0.85; p = 0.021) were significantly associated with PFS. The multivariate analysis showed that patients without radiotherapy history were associated with a better PFS (HR, 3.71; 95% CI: 1.31-10.55; p = 0.014) than patients with radiotherapy history. Patients in combination group reported pneumothorax (8.3%), leukopenia (33.3%), thrombocytopenia (12.5%), diarrhea (4.2%), and anemia (4.2%) as the most frequent grade 3 or higher treatment-emergent AEs (TEAEs), while there was no severe TEAEs occurred in the monotherapy group.
CONCLUSIONS: Fruquintinib-based therapy displayed an optimal tumor control and an acceptable safety profile in patients with advanced or metastatic sarcoma.
METHODS: Patients with advanced or metastatic sarcoma were divided into two groups. One group received fruquintinib monotherapy, while the other received fruquintinib combined therapy. Safety and efficacy of fruquintinib-based therapy were recorded and reviewed retrospectively, including progression-free survival (PFS), overall response rate (ORR), and adverse events (AEs).
RESULTS: Between August 2021 and December 2022, 38 sarcoma patients were retrospectively included. A total of 14 patients received fruquintinib alone (including 6 STS and 8 bone sarcoma), while 24 were treated with fruquintinib combined therapy (including 2 STS and 22 bone sarcoma). The median follow-up was 10.2 months (95% CI, 6.4-11.5). For the entire population, the median PFS was 8.0 months (95% CI, 5.5-13.0). The ORR was 13.1%, while the disease control rate (DCR) was 86.8%. The univariate analysis showed that radiotherapy history (HR, 4.56; 95% CI, 1.70-12.24; p = 0.003), bone sarcoma (HR, 0.34; 95% CI, 0.14-0.87; p = 0.024), and treatment method of fruquintinib (HR, 0.36; 95% CI, 0.15-0.85; p = 0.021) were significantly associated with PFS. The multivariate analysis showed that patients without radiotherapy history were associated with a better PFS (HR, 3.71; 95% CI: 1.31-10.55; p = 0.014) than patients with radiotherapy history. Patients in combination group reported pneumothorax (8.3%), leukopenia (33.3%), thrombocytopenia (12.5%), diarrhea (4.2%), and anemia (4.2%) as the most frequent grade 3 or higher treatment-emergent AEs (TEAEs), while there was no severe TEAEs occurred in the monotherapy group.
CONCLUSIONS: Fruquintinib-based therapy displayed an optimal tumor control and an acceptable safety profile in patients with advanced or metastatic sarcoma.
摘要：
背景：本研究的目的是评估以氟喹替尼为基础的疗法作为晚期或转移性肉瘤患者的抢救疗法的疗效和安全性，包括软组织肉瘤（STS）和骨肉瘤。
方法：将晚期或转移性肉瘤患者分为两组。一组接受氟喹替尼单药治疗，而另一例则接受了氟喹替尼联合治疗。对以氟喹替尼为基础的治疗的安全性和有效性进行了记录和回顾性评价。包括无进展生存期（PFS），总反应率（ORR），和不良事件（AE）。
结果：在2021年8月至2022年12月之间，回顾性纳入了38例肉瘤患者。共有14例患者单独接受了氟喹替尼（包括6例STS和8例骨肉瘤），而24例接受了氟喹替尼联合治疗(包括2例STS和22例骨肉瘤)。中位随访时间为10.2个月(95%CI,6.4-11.5)。对于整个人口来说，中位PFS为8.0个月(95%CI,5.5-13.0).ORR为13.1%，疾病控制率(DCR)为86.8%。单因素分析显示放疗史(HR,4.56；95%CI，1.70-12.24；p=0.003），骨肉瘤（HR，0.34；95%CI，0.14-0.87；p=0.024），和氟喹替尼的治疗方法（HR，0.36；95%CI，0.15-0.85；p=0.021）与PFS显著相关。多因素分析显示,无放疗史患者PFS较好(HR,3.71；95%CI：1.31-10.55；p=0.014）比有放疗史的患者多。联合组患者报告气胸（8.3%），白细胞减少症（33.3%），血小板减少症（12.5%），腹泻（4.2%），贫血（4.2%）是最常见的3级或更高的治疗紧急AE（TEAE），而单药治疗组无严重TEAE发生。
结论：基于Fruquintinib的治疗在晚期或转移性肉瘤患者中显示出最佳的肿瘤控制和可接受的安全性。
方法：将晚期或转移性肉瘤患者分为两组。一组接受氟喹替尼单药治疗，而另一例则接受了氟喹替尼联合治疗。对以氟喹替尼为基础的治疗的安全性和有效性进行了记录和回顾性评价。包括无进展生存期（PFS），总反应率（ORR），和不良事件（AE）。
结果：在2021年8月至2022年12月之间，回顾性纳入了38例肉瘤患者。共有14例患者单独接受了氟喹替尼（包括6例STS和8例骨肉瘤），而24例接受了氟喹替尼联合治疗(包括2例STS和22例骨肉瘤)。中位随访时间为10.2个月(95%CI,6.4-11.5)。对于整个人口来说，中位PFS为8.0个月(95%CI,5.5-13.0).ORR为13.1%，疾病控制率(DCR)为86.8%。单因素分析显示放疗史(HR,4.56；95%CI，1.70-12.24；p=0.003），骨肉瘤（HR，0.34；95%CI，0.14-0.87；p=0.024），和氟喹替尼的治疗方法（HR，0.36；95%CI，0.15-0.85；p=0.021）与PFS显著相关。多因素分析显示,无放疗史患者PFS较好(HR,3.71；95%CI：1.31-10.55；p=0.014）比有放疗史的患者多。联合组患者报告气胸（8.3%），白细胞减少症（33.3%），血小板减少症（12.5%），腹泻（4.2%），贫血（4.2%）是最常见的3级或更高的治疗紧急AE（TEAE），而单药治疗组无严重TEAE发生。
结论：基于Fruquintinib的治疗在晚期或转移性肉瘤患者中显示出最佳的肿瘤控制和可接受的安全性。
